1. Field of the Invention
The present invention relates to a method and dosage form for manufacturing pharmaceutical doses. More particularly the present invention relates to a method for manufacturing pharmaceutical doses on an ingestible sheet.
2. Description of the Art
Oral administration of pharmaceuticals is one of the most widely used methods to provide effective therapy for a variety of illnesses. Many powdered medications are typically administered orally to a person in a dosage form such as tablets or capsules, while still others are in liquid form. The release of orally administered medications falls into two broad categories, buccal or sublingual administration, and oral dissolution. For example, enteric coated tablets that release the medication in the intestinal tract of the patient. Further, many individuals suffer from chronic health problems that require the regular administration of medicaments. Diseases such as diabetes, allergies, epilepsy, heart problems, AIDS, and even cancer requires the regular delivery of precise doses of medicaments if patients are to survive over long periods of time. Such chronic treatment creates the need to regularly obtain additional medication. This can be extremely troublesome for those patients that lack the mobility to easily travel to a pharmacist to refill medications, such as the elderly and infirm. Thus, a method and a dosage form that provides the ability to make custom doses, outside of the large pharmaceutical manufacturing plants, is desirable.
Most pharmaceuticals involve dosage units in the microgram to milligram range of the purified active ingredient or ingredients. Thus, many pharmaceutical doses in tablet or liquid form are made in formulations of a predetermined quantity of pharmaceutical units in each dose. Such pharmaceutical doses are frequently available in fixed different strengths, such as 50 mg, 100 mg, etc.
Unfortunately, such conventional oral dosage forms suffer from a number of disadvantages. Typically, to effectively handle and dispense small doses a considerable amount of adjuvant material must be added in order that the final dosage form is of a manageable size. Thus, typical methods for manufacturing include the mixing of the pure drug with various other substances commonly referred to as excipients or diluents that are therapeutically inert and acceptable by regulatory bodies, such as the FDA. Excipients may also protect the drug from deterioration by oxidation, humidity, and light. Palatability can be improved through the addition of flavorants and identification by use of colorants. This mixing process often requires the use of sophisticated, complex expensive machinery. Certain excipients may be needed to improve the flowability of the drug and diluents through the mixing machinery. Therefore, a method and dosage form that reduces the mixing of the active drug with other substances, and utilizes less complex and expensive machinery would also be desirable.
These therapeutically inactive or inert materials also have the disadvantage that each such material must be evaluated before use in terms of potential incompatibilities with the medicaments present. For example, some of these materials, such as lubricants or disintegrants, may present problems concerning the bioavailability of the active ingredient. Further, the certification of new drugs is a lengthy and costly process involving animal studies followed by chemical trials to establish both the efficacy and safety of the new drug. Because a pharmaceutical's characteristics may be affected by changes in manufacturing and/or packaging, the approval process limits the approval to a particular manufacturing and packaging process. Thus, the ability to rapidly and easily change dosage units is extremely limited in conventional pharmaceutical manufacturing processes.
Drugs with a narrow therapeutic range must also be precisely dosed. If the patient falls below the range, the desired effect will not occur. However, if the patient is above the range then the risk of toxic effects increases. Clinicians assume the dose units manufactured are uniform and that generic equivalents have equal bioavailability. The many FDA generic formulation rejections and recalls for pharmaceuticals that have too high or low of a drug level, however, are evidence that accuracy and precision are still challenges for pharmaceutical manufacturing.
The ability to easily make a custom dose using tablets or capsules utilizing current technology is also difficult. It is virtually impossible to split or divide a capsule to decrease the dose administered requiring that the smallest dose be predetermined. Further, in the case of tablets a patient or pharmacist may often encounter difficulty in splitting or dividing even relatively large tablets that have a notch or groove at a predetermined breaking point to form a lower dosage unit. The splitting or breaking often results in fragments of unequal size. Thus, a method and dosage form that allows for variable doses to be formed outside the pharmaceutical manufacturing plant is desirable.